Monoclonal Antibody Treatment
What is Monoclonal Antibody Treatment?
If you have tested positive for COVID-19 and meet certain eligibility criteria, you may be able to get monoclonal antibody treatment to help you recover. Treatment can lower the amount of virus in your body, reduce symptoms and help avoid hospitalization.
Monoclonal antibodies are made in a lab and work similarly to antibodies your immune system makes to fight infection. Monoclonal antibody treatment helps your body fight COVID-19 while your immune system begins to make its own antibodies. In clinical studies, monoclonal antibody treatments were shown to be safe and effective.
For monoclonal antibody therapy to be most effective, it needs to be taken as early in the disease course as possible. Treatment is usually given by intravenous (IV) infusion and takes about an hour. Some treatments can also be given by injection. With both options, patients are observed for an additional hour to make sure they do not have any immediate bad reactions.
Who is Eligible?
Monoclonal antibody treatments are available to people who have tested positive for COVID-19, have mild to moderate symptoms, and are at high risk of developing severe illness. Treatments are not a substitute for vaccination against COVID-19. Getting vaccinated is the best way to keep from getting sick with COVID-19.
Individuals are eligible to receive monoclonal antibody treatment if all of the following criteria are met:
- Adults and children 12 years or older*
- Weigh at least 40 kg (88.18 lbs)
- Test positive for COVID-19
- Mild or moderate symptoms started within the last 10 days
- Not hospitalized or on oxygen due to COVID-19
- High risk of getting very sick without treatment and/or getting admitted into the hospital, including:
- People who are 65 years old or older
- People who are obese or overweight
- Pregnant people
- People with certain underlying medical conditions
*On Dec. 3, 2021, the FDA expanded its authorization for use of bamlanivimab/etesevimabin to include younger children, including newborns, for the treatment of mild/moderate COVID-19, who meet eligibility criteria.
How to Get Treatment
If you meet eligibility criteria, talk with your doctor or health care provider. Let them know you have tested positive for COVID-19 and want to get monoclonal antibody treatment. If you are eligible, your health care provider will write a prescription for you and help you find a place to get treatment. This process is required to make sure you meet the requirements for treatment before an appointment can be made. If you do not have a healthcare provider, call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.
Information for Healthcare Providers
Currently, there are three monoclonal antibody products (mAb) that are authorized under an Emergency Use Authorization (EUA) by the FDA for treatment of COVID-19 to prevent disease progression in patients at high risk for developing severe COVID-19 disease and/or hospitalization.
The table below includes healthcare provider and patient information sheets for available monoclonal antibody treatments for people infected with COVID-19. These links are updated with the most current versions of the EUA guidance from FDA. Due to the rapidly evolving nature of the pandemic, it is recommended providers reference the HHS ASPR website for the latest updates on monoclonal antibody therapeutics and the NIH website for COVID-19 treatment guidelines.
|Ages Authorized for Use||Method(s) of Administration||Provider Fact Sheets||Patient Information Sheets|
|All ages||Infusion only|
Infusion or injection
The EUAs have foundational patient eligibility criteria for treatment with monoclonal antibodies, which states a patient must have:
- A positive test for COVID-19
- A symptom duration of 10 days or less
- High risk of COVID-19 disease progression as outlined in the EUA fact sheet, and determined by the administering physician/practitioner
Monoclonal antibodies are administered over 20-50 minutes with an IV infusion. REGEN-COV can also be given with four subcutaneous injections. All therapies administered It is required that monoclonal antibody treatments be administered in a setting where providers have direct access to medications to manage potentially severe adverse reactions.
Monoclonal antibody products are being allocated through the Arizona Department of Health Services through a federally coordinated distribution system. For more information on the mAb ordering process and additional clinician resources, please visit the ADHS website.
Additional clinician resources for monoclonal antibody treatments can be found on the National Institutes of Health website.
Referring Patients for mAb Treatment
The Arizona Department of Health Services recommends Arizona healthcare practitioners contact the Arizona Poison Control Systems COVID-19 Hotline (844-542-8201) to find a site close to them that is administering monoclonal antibody therapies. Alternatively, the most up-to-date federal treatment locator is here Version OptionsMonoclonal Antibody TreatmentHeadline. Please note availability of mAb may vary at each location. It is highly encouraged to call ahead for hours of operation, treatment availability, and documentation requirements. More information for providers is available on the ADHS website.
Maricopa County Department of Public Health is working with healthcare systems as well as state and federal partners to increase staffing resources to expand the administration of mAb treatment within the county. FEMA teams and Maricopa County volunteers will help staff mAb treatment sites to help relieve burden on emergency room resources beginning in early January 2022. Sites will be located within existing hospital systems as well as offsite infusion center locations.